Home NDC 63629-8796 Cilostazol
Product NDC 63629-8796
11-digit product format 636298796
Labeler code 63629
Product ID 63629-8796_27535865-53dd-4cd0-b428-8901daac6c52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cilostazol
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077027
Marketing category ANDA
Marketing start 2012-04-24
Substance CILOSTAZOL
Active strength 50 mg/1
Pharmacologic classes Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077027-001 CILOSTAZOL CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 A077027-002 CILOSTAZOL CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cilostazol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CILOSTAZOL 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N7Z035406B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242462 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8796-1 Cilostazol 60 in 1 BOTTLE TABLET 60 107
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8796 CILOSTAZOL TABLET [BRYANT RANCH PREPACK] 107 Current NDC, Legacy NDC, 1 package rows 20240807_f728395c-684c-4087-a389-c323dbcb72dd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CILOSTAZOL CILOSTAZOL direct rx b57d3c1e-e36f-5255-e053-2a95a90ada83 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 Cilostazol CILOSTAZOL Bryant Ranch Prepack f728395c-684c-4087-a389-c323dbcb72dd 2024-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 63629-8796 Cilostazol CILOSTAZOL Bryant Ranch Prepack 53486382-eee0-4cbe-bc4a-a57484e0d5a7 2024-01-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 Cilostazol CILOSTAZOL Teva Pharmaceuticals USA, Inc. a6292311-9cb2-49ff-b8bf-12e2dbd196cd 2022-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8796-1 63629879601 60 TABLET in 1 BOTTLE (63629-8796-1) 60 tablet 2022-08-30 0000-00-00 No No Current